Registration Dossier

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

In a guinea pig maximization assay conducted by BASF (1979a), 3/10 females exhibited a slight skin response (erythema score 1) 24 h after induction and challenge with a 50% aqueous methanol solution (0.1 mL), which can be interpreted as weak sensitizing potential. In another BASF study (1979b) using 12 female animals at a concentration of 50% methanol, 1/12 exhibited a slight skin response (erythema score 1) 24 and 48 h after challenge which can also be interpreted as a weak sensitising potential. The intracutaneous inductions produced necroses and some open ulcerations in both studies.

In summary, the low number of 4/22 animals with slight erythema (score 1) gives no evidence of a notable sensitisation potential of methanol.

An intracutaneous skin sensitisation test was performed with guinea pigs (Landsteiner and Jacobs method), by using 0.1 ml of 0.1% KOH induction injections and a 0.1 ml challenge injection. No allergic skin reactions were observed after 24, 48 and 72 hours following the challenge dose (Johnson, 1975). Potassium hydroxide has been used extensively for many decades by the industry and by consumers. However, skin sensitisation has never been described secondary to skin irritation or burns. Both the potassium and the hydroxide are ions, which are naturally, present in the body and for this reason it is very unlikely that they could cause skin sensitisation (OECD SIDS KOH).

Overall, the registered substance is considered not to be a skin sensitiser.


Migrated from Short description of key information:
Mathanol: A guinea pig maximization assay gave no evidence of contact sensitization after induction and challenge doses of 50%.
KOH: Based on the data available and on the above, it may be concluded that potassium hydroxide is not an allergen in humans (OECD SIDS KOH).

Justification for classification or non-classification

The registered substance is considered not to be a skin sensitiser. Therefore, no classification is required.